Bosentan

Type: Product
Name: Bosentan
First reported Apr 17 2014 - Updated Apr 17 2014 - 4 reports

Actelion's CEO Discusses Q1 2014 Results - Earnings Call Transcript

Actelion Ltd ( OTCPK:ALIOF ) Q1 2014 Earnings Conference Call April 17, 2014 8:00 AM ETOperatorWelcome to the Actelion First Quarter 2014 Financial Results Conference Call. As a reminder all participant are in a listen-only mode. After the presentation, ... [Published Seeking Alpha - Apr 17 2014]
First reported Apr 17 2014 - Updated Apr 17 2014 - 1 reports

Using a Drug-Safety Tool to Prevent Competition

In 2007, the Food and Drug Administration Amendments Act (FDAAA) created an important new tool for dealing with drugs that have potential safety problems: the Risk Evaluation and Mitigation Strategy (REMS). The aim was to encourage prescribers and patients ... [Published New England Journal of Medicine - Apr 17 2014]
First reported Apr 04 2014 - Updated Apr 04 2014 - 2 reports

Another REMS Antitrust Lawsuit: Mylan Sues Celgene

By Kurt R. Karst –In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust ... [Published MedCity News - Apr 04 2014]
First reported Apr 01 2014 - Updated Apr 02 2014 - 1 reports

Bayer’s Adempas gains EU clearance for two forms of PAH

Following a previous positive opinion from the European Medicines Agency’s advisory committee (The Pharma Letter January 24), the European Commission has approved German pharma major Bayer’s (BAYN: DE) Adempas (riociguat) for the treatment of chronic ... [Published Pharma Letter - Apr 01 2014]
First reported Mar 19 2014 - Updated Mar 19 2014 - 1 reports

Actelion lifts annual guidance following better than expected Opsumit launch

Actelion announced Tuesday alongside its full-year financial results that it now expects core earnings growth in the low single digits on a constant currency basis for 2014, lifted from a previous forecast of earnings to be at least at the 2013 level. ... [Published FirstWord Pharma - Mar 19 2014]
First reported Mar 18 2014 - Updated Mar 18 2014 - 4 reports

Actelion's Tracleer Misses Primary Endpoint - Analyst Blog

The primary endpoint was to demonstrate that Tracleer prolonged the time to first morbidity or mortality event in patients with symptomatic PAH already receiving Revatio. Tracleer showed a risk reduction of 17% as compared to 43% in the primary endpo ... [Published Nasdaq - Mar 18 2014]
First reported Mar 18 2014 - Updated Mar 18 2014 - 1 reports

Actelions Tracleer fails to hit targets in Ph IV

A post-marketing study of Actelion's Tracleer (bosentan) assessing its ability to delay death in patients with high blood pressure has failed to hit ... ... [Published Big News Network - Mar 18 2014]
First reported Mar 17 2014 - Updated Mar 18 2014 - 3 reports

Actelion's Update on Asahi Litigation - Analyst Blog

Actelion Ltd. (ALIOF) possesses a leading franchise in pulmonary arterial hypertension (PAH) with four products for this indication, namely, Tracleer, Ventavis, Veletri and Opsumit.Opsumit was approved by the U.S. Food and Drug Administration on Oct 18, ... [Published Benzinga.com - Mar 17 2014]
First reported Mar 17 2014 - Updated Mar 17 2014 - 6 reports

Actelion's Tracleer fails to hit targets in Ph IV

A post-marketing study of Actelion's Tracleer (bosentan) assessing its ability to delay death in patients with high blood pressure has failed to hit targets.The Phase IV trial did not meet its primary endpoint of time to first morbidity or mortality event ... [Published Pharma Times - Mar 17 2014]
First reported Mar 17 2014 - Updated Mar 17 2014 - 2 reports

CORRECTED-Swiss stocks - Factors to watch on March 17

(Corrects to remove reference to placebo in Actelion's Tracleer)ZURICH, March 17 (Reuters) - Swiss stocks were expected to open lower on Monday, with the threat of sanctions against Russia ... ... [Published Big News Network - Mar 17 2014]
First reported Mar 17 2014 - Updated Mar 17 2014 - 1 reports

Swiss Shares Snap Losing Streak As Ukraine Remains Calm

Swiss stocks edged higher on Monday, ending a week-long losing streak after Crimea's vote to secede Ukraine generated no major violence.Upbeat U.S. data and tame Euro zone inflation also gave markets a boost.The Swiss Market Index (SMI) rose 0.59 percent ... [Published RTTNews.com - Mar 17 2014]
First reported Mar 13 2014 - Updated Mar 14 2014 - 2 reports

High court dashes Actelions hopes for $407M reprieve in Tracleer case

Actelion has lost its fight against a $407 million court judgment. California's Supreme Court rebuffed the Swiss drugmaker's appeal in a lawsuit over competition for its top-selling drug, ... ... [Published Big News Network - Mar 14 2014]

Quotes

...Further launches throughout Europe are forthcoming, as well as a regulatory filing for Opsumit in Japan." Mr Clozel concluded: "Based on this good start to the year, Actelion will be well positioned to review its guidance for core earnings growth by mid-year."
"While information regarding monitored pressure may be employed in a closed-loop system, it will be understood that such information may be valuable in open-loop systems. For example, information regarding monitored pressure may be transmitted or otherwise provided to a physician, who may then determine, in their medical judgment, whether to adjust the dosage of therapeutic agent based on the pressure and other suitable factors."
..." Clozel noted that the company plans to seek approval of selexipag this year, with a possible launch in 2015. The executive also said that the "antibiotic agent cadazolid, currently enrolling in Phase III , provides the opportunity to build an additional specialty franchise by 2016."
Vallerie McLaughlin of the University of MichiganUniversity of Michigan Ann Arbor, USA, and chairman of the COMPASS-2 Steering Committee, commented: "While the observed risk reduction of 17% did not reach statistical significance, I am convinced that this study provides important information for the scientific community and we are committed to perform all the necessary analyses to fully understand the outcome of the study."

More Content

All (35) | News (34) | Reports (0) | Blogs (1) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
sort by: Date | Relevance
Actelion's CEO Discusses Q1 2014 Results - Earn... [Published Seeking Alpha - Apr 17 2014]
Using a Drug-Safety Tool to Prevent Competition [Published New England Journal of Medicine - Apr 17 2014]
Actelion Beats on Q1 Earnings and Sales [Published Yahoo! Finance - Apr 17 2014]
Actelion posts strong first-quarter 2014 results [Published Pharma Letter - Apr 17 2014]
UPDATE 1-Actelion flags possible mid-year guida... [Published Reuters - Apr 17 2014]
Another REMS Antitrust Lawsuit: Mylan Sues Celgene [Published MedCity News - Apr 04 2014]
Another REMS Antitrust Lawsuit: Mylan Sues Celg... [Published FDA Law Blog - Apr 04 2014]
Bayer’s Adempas gains EU clearance for two form... [Published Pharma Letter - Apr 01 2014]
MEDTRONIC : Patent Issued for Pressure Monitori... [Published 4 Traders - Mar 26 2014]
Actelion lifts annual guidance following better... [Published FirstWord Pharma - Mar 19 2014]
Actelion's Tracleer Misses Primary Endpoint - A... [Published Nasdaq - Mar 18 2014]
Bosentan Comes up Empty in Postmarket PAH Trial [Published Diabetes Care - Mar 18 2014]
Actelion's Tracleer Misses Primary Endpoint [Published Zacks.com - Mar 18 2014]
Actelion's Tracleer Misses Primary Endpoint [Published Yahoo! Finance - Mar 18 2014]
Actelions Tracleer fails to hit targets in Ph IV [Published Big News Network - Mar 18 2014]
Actelion's Tracleer fails to hit targets in Ph IV [Published Pharma Times - Mar 17 2014]
CORRECTED-Swiss stocks - Factors to watch on Ma... [Published Big News Network - Mar 17 2014]
Bosentan study doesn’t meet endpoint [Published MedNous - Mar 17 2014]
Phase 4 Actelion Study Misses Primary Endpoint [Published One News Page - Mar 17 2014]
Phase 4 Actelion Study Misses Primary Endpoint [Published Forbes.com - Mar 17 2014]
Swiss Shares Snap Losing Streak As Ukraine Rema... [Published RTTNews.com - Mar 17 2014]
Actelion's Update on Asahi Litigation - Analyst... [Published Benzinga.com - Mar 17 2014]
Actelion's Update on Asahi Litigation - Analyst... [Published Zacks.com - Mar 17 2014]
Actelion's Update on Asahi Litigation [Published Yahoo! Finance - Mar 17 2014]
Actelion says COMPASS-2 bosentan study fails pr... [Published Pharma Letter - Mar 17 2014]
EUROPEAN EQUITY OPENING HEADLINES INCLUDING: As... [Published Proactiveinvestors United Kingdom RSS feed - Mar 17 2014]
CORRECTED-Swiss stocks - Factors to watch on Ma... [Published Reuters - Mar 17 2014]
Actelion Says Bosentan Study Fails To Meet Prim... [Published RTTNews.com - Mar 17 2014]
US Court upholds damages award in Actelion/Asah... [Published Pharma Letter - Mar 14 2014]
High court dashes Actelions hopes for $407M rep... [Published Big News Network - Mar 14 2014]
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Another REMS Antitrust Lawsuit: Mylan Sues Celg... [Published FDA Law Blog - Apr 04 2014]
By Kurt R. Karst –In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust ...
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